Catheter reinforcing assembly and balloon dilatation catheter

Abstract

The utility model discloses a catheter reinforcing assembly and a balloon dilatation catheter, and relates to the technical field of medical instruments, the catheter reinforcing assembly comprises a first fixing piece, a second fixing piece and a connecting piece, the first fixing piece is arranged between a near-end tube leg and an inner cavity tube, and the second fixing piece is arranged between a far-end tube leg and the inner cavity tube; the connecting piece is connected between the first fixing piece and the second fixing piece, and the connecting piece is made of a rigid material. When the balloon is pressurized and expanded, the near-end tube leg and the far-end tube leg are limited by the connecting piece by being connected with the first fixing piece and the second fixing piece respectively, so that the balloon cannot deform in the axial direction and can only deform and expand in the radial direction, and then axial tensile deformation of the corresponding inner cavity tube in the balloon can be prevented.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and more specifically, to a catheter reinforcement component and a balloon dilation catheter. Background Technology

[0002] Balloon dilation catheters are mainly used clinically in minimally invasive surgeries such as percutaneous coronary angioplasty and treatment of arterial stenosis to treat vascular stenosis, dilate blood vessels, reshape them, and restore the physiological diameter of blood vessels. During the procedure, after successful puncture and establishment of a channel, the balloon portion of the balloon dilation catheter is placed at the site of the vascular lesion. Pressure is applied to inflate the balloon, repositioning the blocked blood vessel and creating a complete channel. After dilation, the balloon is withdrawn to a negative pressure state and removed from the blood vessel.

[0003] Currently, in the manufacturing process of balloon dilation catheters, the proximal and distal legs of the balloon are typically welded to the inner lumen to secure the balloon and ensure its airtightness. However, during use, due to the differences in structure and materials between the balloon and the inner lumen, the balloon undergoes axial and radial deformation during inflation, and correspondingly, the inner lumen also deforms axially. When the balloon is depressurized, due to the difference in tensile strength between the balloon and the inner lumen, the inner lumen undergoes plastic deformation and cannot return to its initial length, making the balloon dilation catheter unusable.

[0004] Therefore, how to avoid axial deformation of the inner tube during balloon inflation has become a technical problem that urgently needs to be solved by those skilled in the art. Utility Model Content

[0005] In view of this, the purpose of this utility model is to provide a catheter reinforcement component to avoid axial deformation of the inner tube during balloon inflation.

[0006] Another objective of this invention is to provide a balloon dilation catheter including the aforementioned catheter reinforcement components.

[0007] To achieve the above objectives, the present invention provides the following technical solutions:

[0008] A catheter reinforcement assembly is disposed between a balloon and an endouren tube, the balloon including a proximal leg and a distal leg, both the proximal leg and the distal leg being connected to the endouren tube, comprising:

[0009] A first fixing member is disposed between the proximal tube leg and the inner lumen tube;

[0010] The second fixing member is disposed between the distal tube leg and the inner tube.

[0011] A connector is provided between the first fixing member and the second fixing member, and the connector is made of a rigid material.

[0012] Optionally, in the above-described catheter reinforcement assembly, the first fixing member is an annular structure and is fitted between the proximal leg and the inner lumen tube; and / or,

[0013] The second fastener is a ring-shaped structure and is fitted between the distal leg and the inner tube.

[0014] Optionally, in the above-described catheter reinforcement assembly, the first fixing member has a first connecting hole, at which the proximal leg and the inner lumen tube are connected; and / or,

[0015] The second fixing member has a second connecting hole, at which the distal tube leg is connected to the inner tube.

[0016] Optionally, in the aforementioned catheter reinforcement assembly, a first connecting post is provided on the outer wall of the inner lumen tube for embedding in the first connecting hole and connecting to the proximal leg; and / or,

[0017] The outer wall of the inner tube is provided with a second connecting post for embedding the second connecting hole and connecting to the distal tube leg.

[0018] Optionally, in the above-described conduit reinforcement assembly, the first fixing member includes two semi-annular structures, each of which has the first connecting hole and is connected to the connecting member, and the two semi-annular structures are joined together to form the first fixing member; and / or,

[0019] The second fastener includes two semi-annular structures, each of which has a second connecting hole and is connected to the connector. The two semi-annular structures are joined together to form the second fastener.

[0020] Optionally, in the above-described conduit reinforcement assembly, the connector includes a plurality of connecting strips, the two ends of which are respectively connected to the first fixing member and the second fixing member, and the connecting strips are made of a rigid material.

[0021] Optionally, in the above-described conduit reinforcement assembly, the connecting strip includes multiple segmented structural strips that are sequentially hinged together, and the segmented structural strips are made of a rigid material.

[0022] Optionally, in the above-described conduit reinforcement assembly, the connectors are uniformly arranged circumferentially along the first and second fixing members; and / or,

[0023] The first fixing member and / or the second fixing member are provided with mounting grooves for the end of the connector to be inserted.

[0024] Optionally, in the above-described catheter reinforcement assembly, the first fixing member and / or the second fixing member are made of stainless steel or radiopaque material; and / or,

[0025] The connector is made of stainless steel.

[0026] A balloon dilation catheter includes the catheter reinforcement assembly described above.

[0027] The catheter reinforcement assembly provided by this utility model includes a first fixing member, a second fixing member, and a connector. The first fixing member is disposed between the proximal leg and the inner lumen, the second fixing member is disposed between the distal leg and the inner lumen, and the connector connects the first and second fixing members, and the connector is made of a rigid material. During balloon inflation, the proximal and distal legs are restricted by the connector through their connection with the first and second fixing members, preventing the balloon from deforming axially and allowing it to expand only radially. This prevents axial tensile deformation of the corresponding inner lumen within the balloon. Compared to existing technologies, the catheter reinforcement assembly provided by this utility model effectively avoids axial tensile deformation of the inner lumen through the connector, allowing the balloon dilation catheter to be reused.

[0028] The balloon dilation catheter disclosed in this embodiment includes the catheter reinforcement component described above. Because it has the catheter reinforcement component, it also has the aforementioned beneficial effects. Other structures can be referred to in the prior art, and will not be described in detail here. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0030] Figure 1 This is an isometric view of the balloon dilation catheter disclosed in an embodiment of this utility model;

[0031] Figure 2 This is a front view of the balloon dilation catheter disclosed in an embodiment of the present utility model.

[0032] Figure 3 for Figure 2 Sectional view at point AA;

[0033] Figure 4 for Figure 2Cross-sectional view at the middle BB;

[0034] Figure 5 This is a schematic diagram of the assembly structure of the catheter reinforcement component and the inner lumen tube disclosed in an embodiment of the present invention. Figure 1 ;

[0035] Figure 6 This is a schematic diagram of the assembly structure of the catheter reinforcement component and the inner lumen tube disclosed in an embodiment of the present invention. Figure 2 ;

[0036] Figure 7 This is an isometric view of the first type of conduit reinforcement assembly disclosed in this utility model embodiment;

[0037] Figure 8 This is a front view of the first type of catheter reinforcement assembly disclosed in this utility model embodiment;

[0038] Figure 9 This is a cross-sectional view of the first type of catheter reinforcement assembly disclosed in this utility model embodiment;

[0039] Figure 10 This is an isometric view of the second type of conduit reinforcement assembly disclosed in this utility model embodiment;

[0040] Figure 11 This is a front view of the second type of catheter reinforcement assembly disclosed in this embodiment of the present utility model;

[0041] Figure 12 This is a cross-sectional view of the second type of catheter reinforcement assembly disclosed in this utility model embodiment;

[0042] Figure 13 for Figure 12 Enlarged view of point C in the middle;

[0043] Figure 14 for Figure 12 Enlarged view of point D in the middle;

[0044] Figure 15 This is a front view of the first fastener disclosed in an embodiment of the present utility model;

[0045] Figure 16 This is a cross-sectional view of the first fastener disclosed in an embodiment of the present utility model.

[0046] Among them, 100 is a catheter reinforcement assembly, 110 is a first fixing member, 111 is a first connecting hole, 112 is a mounting slot, 120 is a second fixing member, 121 is a second connecting hole, 130 is a connecting member, 131 is a segmented structural bar, and 132 is a hanging hole;

[0047] 200 is the balloon, 210 is the proximal leg, and 220 is the distal leg;

[0048] 300 is an inner cavity tube. DETAILED DESCRIPTION

[0049] The core of this utility model lies in disclosing a catheter reinforcement component to prevent axial deformation of the inner tube during balloon inflation.

[0050] Another key aspect of this invention is the disclosure of a balloon dilation catheter that includes the aforementioned catheter reinforcement components.

[0051] Hereinafter, embodiments will be described with reference to the accompanying drawings. Furthermore, the embodiments shown below do not limit the scope of the utility model as described in the claims. Additionally, the complete contents of the structures represented in the embodiments below are not limited to those necessary for the solution of the utility model as described in the claims. It should be noted that, for ease of description, only the parts relevant to the utility model are shown in the drawings. Unless otherwise specified, the embodiments and features in the embodiments of this utility model can be combined with each other.

[0052] It should be noted that in this article, "proximal" and "distal" refer to the distance from the operator. The end closer to the operator is called the "proximal" end, and the end farther from the operator is called the "distal" end.

[0053] Combine Figures 1-16 The catheter reinforcement assembly 100 disclosed in this embodiment of the present invention is used to be disposed between the balloon 200 and the inner tube 300. The balloon 200 includes a proximal leg 210 and a distal leg 220 (the leg located at the proximal end of the balloon body is the proximal leg 210, and the leg located at the distal end of the balloon body is the distal leg 220). Both the proximal leg 210 and the distal leg 220 are connected to the inner tube 300 to realize the connection between the inner tube 300 and the balloon 200 and the mutual isolation between the balloon body of the balloon 200 and the tube body of the inner tube 300. The catheter reinforcement assembly 100 includes a first fixing member 110, a second fixing member 120, and a connector 130. The first fixing member 110 is disposed between the proximal leg 210 and the inner lumen 300, the second fixing member 120 is disposed between the distal leg 220 and the inner lumen 300, and the connector 130 is connected between the first fixing member 110 and the second fixing member 120, and the connector 130 is made of a rigid material.

[0054] When the balloon 200 is inflated and expanded, the axial dimension of the balloon 200 will automatically stretch, causing the proximal leg 210 and the distal leg 220 to move away from each other, thereby driving the first fixing member 110 and the second fixing member 120 to move away from each other. At this time, since the connecting member 130 made of rigid material is connected between the first fixing member 110 and the second fixing member 120, the distance between the first fixing member 110 and the second fixing member 120 can remain unchanged, thereby resisting the axial deformation of the balloon 200 and preventing the inner cavity tube 300 from being axially stretched and deformed.

[0055] Compared with the prior art, the catheter reinforcement assembly 100 disclosed in this embodiment of the present invention can effectively avoid axial tensile deformation of the inner lumen tube 300 through the setting of the connector 130, so that the balloon dilation catheter can be reused.

[0056] Specifically, in combination Figure 7 and Figure 10 The first fixing member 110 can be a ring structure and is fitted between the inner wall of the proximal leg 210 and the outer wall of the inner tube 300. The first fixing member 110 is fixedly connected to the proximal leg 210 and the inner tube 300 respectively, thereby realizing the connection between the three.

[0057] The second fastener 120 can be fixed in the same way as the first fastener 110. That is, the second fastener 120 is a ring structure and is fitted between the inner wall of the distal leg 220 and the outer wall of the inner tube 300.

[0058] Those skilled in the art will understand that the proximal leg 210 and distal leg 220 of the balloon 200 are typically welded to the inner tube 300. Therefore, the first fixation member 110 and the second fixation member 120 can also be connected to the balloon 200 and the inner tube 300 by welding.

[0059] A further optimization solution is to open a first connecting hole 111 on the first fixing member 110, and the proximal tube leg 210 can be connected to the inner cavity tube 300 at the first connecting hole 111, so that the first fixing member 110 can be simultaneously pressed between the proximal tube leg 210 and the inner cavity tube 300 by simply connecting the proximal tube leg 210 and the inner cavity tube 300 together, without the need to connect the first fixing member 110 and the proximal tube leg 210 and the first fixing member 110 and the inner cavity tube 300 separately.

[0060] See also Figures 7-12 The first connecting hole 111 can be evenly opened along the circumference of the first fixing member 110, and can be arranged in multiple circles along the axial direction of the first fixing member 110 to ensure the reliability of the connection.

[0061] A second connecting hole 121 may also be provided on the second fixing member 120, at which the distal leg 220 and the inner tube 300 are connected. The specific arrangement of the second connecting hole 121 may be the same as that of the first connecting hole 111, and will not be described in detail here.

[0062] It is understandable that during the preparation of the balloon dilation catheter, the catheter reinforcement component 100 can be assembled into the preset position of the inner lumen tube 300 first, and then the balloon 200 and the inner lumen tube 300 can be assembled.

[0063] Specifically, a first connecting post can be provided at the position where the inner tube 300 is connected to the first fixing member 110. The position of the first connecting post corresponds to the position of the first connecting hole 111. The positioning and assembly of the inner tube 300 and the first fixing member 110 can be realized through the first connecting hole 111 and the first connecting post. After the first connecting post passes through the first connecting hole 111, it can also facilitate the connection between the inner tube 300 and the proximal tube leg 210.

[0064] The first connecting post can be integrally formed on the outer wall of the inner tube 300. A corresponding second connecting post can be provided on the outer wall of the inner tube 300 for engaging with the second connecting hole 121 and connecting to the distal leg 220. This description is omitted here. It is understood that, in addition to the inner tube 300, the first and second connecting posts can also be provided on the proximal leg 210 and distal leg 220 of the balloon 200, respectively, for connection to the inner tube 300.

[0065] After the first connecting column and the second connecting column are arranged on the outer wall of the inner cavity tube 300, in order to facilitate the assembly of the first fixing member 110 and the second fixing member 120 with the inner cavity tube 300, the first fixing member 110 and the second fixing member 120 can be set to a split structure, so that they can be divided into two independent semi-annular structures, and the connection positions of the connecting member 130 and the first fixing member 110 and the second fixing member 120 avoid the split positions of the first fixing member 110 and the second fixing member 120, so that the first fixing member 110 and the second fixing member 120 can be installed on both sides of the inner cavity tube 300 together with the connecting member 130, and embrace the inner cavity tube 300 to realize the connection between the inner cavity tube 300 and the catheter reinforcement assembly 100.

[0066] Taking the first fixing member 110 of the annular structure as an example, the first fixing member 110 includes two semi-annular structures that are symmetrical to each other and are split structures. The two semi-annular structures can be assembled to form a complete first fixing member 110. Furthermore, positioning grooves and positioning protrusion structures can be respectively set at the end positions where the two semi-annular structures are connected to each other to facilitate the positioning and assembly of the two semi-annular structures, and the two semi-annular structures are symmetrically connected with connecting members 130.

[0067] The second fixing member 120 also includes two semi-annular structures. Both semi-annular structures are provided with a second connection hole 121 and are connected to the connecting member 130 . The two semi-annular structures are combined to form the second fixing member 120 , which will not be described in detail here.

[0068] In one embodiment, combining Figure 7-Figure 9 The connecting member 130 includes a plurality of connecting strips, the two ends of which are respectively connected to the first fixing member 110 and the second fixing member 120. The connecting strips are made of rigid material and can counteract the axial tensile force of the balloon 200 to avoid axial tensile deformation of the inner cavity tube 300.

[0069] Preferably, each connecting strip is evenly arranged along the circumference of the first fixing member 110 and the second fixing member 120.

[0070] Further optimize the solution, combined with Figures 10-12 The connecting strip includes multiple segmented structural strips 131 that are hinged in sequence. The segmented structural strips 131 are made of rigid material, that is, the connecting strip is a multi-segment structure, which makes the catheter reinforcement assembly 100 have better compliance and can follow the balloon dilatation catheter to better pass through the curved position of the blood vessel.

[0071] In some embodiments, the connector 130 may also be a tubular structure made of a rigid material, with its ends respectively connected to the first fixing member 110 and the second fixing member 120, which can also effectively prevent axial tensile deformation of the inner tube 300. In this embodiment, the first fixing member 110, the second fixing member 120, and the connector 130 may be configured as an integrated structure and sleeved on the outer wall of the inner tube 300.

[0072] Specifically, in combination Figures 12-14 Hanging holes 132 are provided at the ends where the segmented structural strips 131 connect. Two adjacent hanging holes 132 are hooked together, achieving a hinged connection between adjacent segmented structural strips 131. (See also...) Figure 15 and Figure 16 A mounting groove 112 is provided at the ends of the first fixing member 110 and the second fixing member 120 close to each other, into which the ends of the connecting member 130 can be embedded. Depending on the specific connection form of the connecting member 130 and the first fixing member 110 and the second fixing member 120 (for example, welding, hanging, etc.), the mounting groove 112 can be a blind groove or a through groove.

[0073] Both the first fixing member 110 and the second fixing member 120 mentioned above can be made of stainless steel. The connector 130 needs to have a certain rigidity. Since the connector 130 is located directly inside the balloon 200 and will be in direct contact with the balloon's filling fluid, it also needs to avoid reacting with the filling fluid. Therefore, the connector 130 can also be made of stainless steel. Specifically, the connector 130 can be a steel bar or a steel wire. Steel bars have higher rigidity, while steel wires have better conformability. Multi-segment steel bars can balance rigidity and conformability. Furthermore, a protective layer can be coated on the surface of the connector 130.

[0074] Those skilled in the art will understand that, during the specific surgical procedure of the balloon dilation catheter, the operator needs to locate the position of the balloon 200 within the human body. Therefore, two contrast rings are typically set on the outer wall of the inner tube 300, corresponding to the proximal and distal positions of the working segment of the balloon 200, respectively. In this embodiment, since the positions of the first fixing member 110 and the second fixing member 120 correspond to the positions of the proximal leg 210 and the distal leg 220 of the balloon 200, respectively, the first fixing member 110 and the second fixing member 120 can be made of materials with contrasting effects, such as platinum-iridium alloy, tantalum, and their alloys, to achieve the marking effect on the working segment of the balloon 200. This allows for the cancellation of the contrast rings on the inner tube 300 or the enhancement of the contrasting effect of the contrast rings on the inner tube 300.

[0075] In one embodiment, both the first fixing member 110 and the second fixing member 120 are stainless steel rings, and both stainless steel rings have a hollow structure to form the aforementioned first connecting hole 111 and second connecting hole 121, facilitating the welding connection between the balloon leg and the inner lumen tube 300 during welding. Multiple mounting grooves 112 are evenly provided circumferentially at the close ends of the first fixing member 110 and the second fixing member 120, and the end of the connector 130 is welded to each mounting groove 112 in a one-to-one correspondence. The connector 130 is a steel wire, steel bar, or a multi-segment steel bar.

[0076] The balloon dilation catheter disclosed in this embodiment of the present invention includes the catheter reinforcement component 100 described above. Since it has the catheter reinforcement component 100, it also has the above-mentioned beneficial effects. Other structures can be referred to the prior art, and will not be described in detail here.

[0077] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Specific technical means in some embodiments may be incorporated in part or in whole into another embodiment, unless expressly excluded by another embodiment. Therefore, the present invention will not be limited to the embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A catheter reinforcement assembly, used to be arranged between a balloon (200) and an inner cavity tube (300), wherein the balloon (200) comprises a proximal tube leg (210) and a distal tube leg (220), wherein the proximal tube leg (210) and the distal tube leg (220) are both connected to the inner cavity tube (300), characterized in that: include: A first fixing member (110) is disposed between the proximal tube leg (210) and the inner cavity tube (300); A second fixing member (120) is disposed between the distal tube leg (220) and the inner cavity tube (300); A connecting member (130) is connected between the first fixing member (110) and the second fixing member (120), and the connecting member (130) is made of a rigid material.

2. The catheter reinforcement assembly according to claim 1, characterized in that: The first fixing member (110) is an annular structure and is disposed between the proximal tube leg (210) and the inner cavity tube (300); and / or, The second fixing member (120) is an annular structure and is disposed in a close fit between the distal tube leg (220) and the inner cavity tube (300).

3. The catheter reinforcement assembly according to claim 2, characterized in that: The first fixing member (110) is provided with a first connection hole (111), and the proximal tube leg (210) and the inner cavity tube (300) are connected at the first connection hole (111); and / or, The second fixing member (120) is provided with a second connection hole (121), and the distal tube leg (220) and the inner cavity tube (300) are connected at the second connection hole (121).

4. The catheter reinforcement assembly according to claim 3, characterized in that: A first connecting column is provided on the outer wall of the inner cavity tube (300) for being embedded in the first connecting hole (111) and connected to the proximal tube leg (210); and / or, A second connecting column is provided on the outer wall of the inner cavity tube (300) and is used to be embedded in the second connecting hole (121) and connected to the distal tube leg (220).

5. The catheter reinforcement assembly according to claim 4, characterized in that: The first fixing member (110) comprises two semi-annular structures, each of which is provided with the first connecting hole (111) and is connected to the connecting member (130), and the two semi-annular structures are embraced to form the first fixing member (110); and / or, The second fixing member (120) comprises two semi-annular structures, each of which is provided with the second connecting hole (121) and is connected to the connecting member (130), and the two semi-annular structures are embraced to form the second fixing member (120).

6. The catheter reinforcement assembly according to any one of claims 1 to 5, characterized in that: The connecting member (130) comprises a plurality of connecting strips, two ends of the connecting strips are respectively connected to the first fixing member (110) and the second fixing member (120), and the connecting strips are made of a rigid material.

7. The catheter reinforcement assembly according to claim 6, characterized in that: The connecting strip comprises a plurality of segmented structural strips (131) which are hinged in sequence, and the segmented structural strips (131) are made of a rigid material.

8. The catheter reinforcement assembly according to claim 6, wherein: The connecting members (130) are evenly arranged along the circumference of the first fixing member (110) and the second fixing member (120); and / or, The first fixing member (110) and / or the second fixing member (120) is provided with a mounting groove (112) for the end of the connecting member (130) to be embedded.

9. The catheter reinforcement assembly according to any one of claims 1 to 5, characterized in that: The first fixing member (110) and / or the second fixing member (120) are made of stainless steel or developing material; and / or, The connecting piece (130) is made of stainless steel.

10. A balloon dilatation catheter, characterized in that: Comprising the catheter reinforcement assembly as described in any one of claims 1-9.

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